跳至主要内容
临床试验/NCT03797742
NCT03797742Unknown不适用

A Clinical Follow-up Study of Heart Failure Patients.

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
NYHA functional class

研究概览

简要总结

Heart failure (HF), a current worldwide pandemic with an unacceptable high level of morbidity and mortality, brings an enormous medical and societal burden. Chronic HF is characterized by progressive alteration of cardiac structure and function. But the molecular mechanism of these alterations is still not well-established and needs to be discussed further. HF is a highly heterogeneous disease that can be caused by a multiple of diseases. Dilated cardiomyopathy (DCM) and ischemic cardiomyopathy (ICM) are the main causes of this syndrome. Although HF is the common manifestation of DCM and ICM, the etiology and pathogenesis are different. Understanding the different pathophysiological mechanisms will contribute to the prevention and individualized therapy of heart failure. Therefore, this study aims to observation the different characteristics of the molecular biology and clinical courses in DCM and ICM patients.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • LVEF≤ 55%
  • enlarged left ventricular end-diastolic dimension
  • ICM group: with history of MI or revascularization; ≥ 75% stenosis of LM or proximal LAD; ≥ 75% stenosis of two or more epicardial vessels.
  • symptomatic heart failure

排除标准

  • Known malignant tumour diseases
  • Pregnancy or lactation period;
  • Investigators think not suitable to participate in this trial.

结局指标

主要结局

NYHA functional class

时间窗: one year after enrolled

NYHA cardiac functional class

All-cause mortality

时间窗: one year after enrolled

All-cause mortality during follow-up

次要结局

  • left ventricular end-diastolic dimension(LVEDD) dilates.(one year after enrolled)
  • left ventricular ejection fraction reduces(one year after enrolled)
  • hospitalization for cardiac causes(one year after enrolled)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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